1. Field of Invention
The present invention pertains to a new and improved additive vial used to transfer liquids into a container. More particularly, this invention relates to an additive vial which is useful in quickly and efficiently transferring medicinal solutions into evacuated containers of intravenous or intramuscular solution or the like.
2. Description of the Art
Bottles of parenteral solution are typically shipped to the administering institution, such as a hospital, in bulk quantity. For efficiency in production, transfer and storage of such bottles, the chemical composition of the parenteral solution is uniform, bottle to bottle, and is not subjected to degradation or contamination solely on account of the age of the solution. However, the chemical composition of the solution administered to the end user, such as a patient, must be tailored according to the individual needs of the user. For example, a patient to be administered a standard intravenous solution, such as distilled water with five percent (5%) glucose, may require a quantity of vitamins, minerals, serums, such as sodium pentothal, or other drugs to be added to the parenteral solution for concurrent intravenous administration.
Medicinal additives have a tendency to degrade over a period of time and, therefore, are preferably added to the intravenous solution just prior to administration to a patient. The additives are typically packaged in five milliliter glass vials provided with a closure having a removable top portion and a hollow spike having both ends sharpened. After removal of the top portion and upon the application of force against the rubber diaphragm of the parenteral solution container, one end of the spike penetrates the container while the other end of the spike substantially simultaneously penetrates a puncturable seal provided on the vial. A vacuum maintained in the parenteral solution container pulls the additive solution therein through the hollow passageway provided in the spike.
The assembly of the closure system for the vials of the prior art is complex. Initially, all of the closure components are usually preassembled before the closure is mounted onto the container. In such preassembly, a double-edged, hollow spike provided with an outwardly projecting rim, auxiliary core slides and the like, is inserted into a rubber stopper until the rim locks into a groove provided in the stopper. The rubber stopper is closed at the end opposite the exposed spike. A first ferrule, designed to hold the stopper onto the vial, is placed over the exposed spike and against a ledge provided on the rubber stopper. A removable overcap is placed over the exposed spike and fits tightly against the rubber stopper. A second metal ferrule, which is removable and is designed to hold the overcap onto the vial, is placed over the overcap and over the first ferrule. The preassembled closure is placed over the mouth of a vial and both ferrules are simultaneously constricted under the bead at the mouth of the vial in one rolling operation.
After the closure and vial are assembled, the assembly must be sterilized. The most common method of sterilization is by exposing the parts to a pressurized steam atmosphere, at a temperature of about 250.degree. F. (120.degree. C.). The cavity surrounding the spike in the closure of the prior art is air tight. In order to insure that steam will be present in such cavity during heating and pressurization, it is necessary to assembly the closure parts in a wet condition. Manual wet assembly is a complicated process. The assembly of such closure systems typically adds significantly to the overall cost of the additive vial.
The vials of the prior art are typically provided with an overcap which is removable by a multiple step process. For example, it is common to have a tear-off ring provided on the top of the vial which must be pulled to sever the ring and thereby render the ring removable. Thereafter, the ring is pulled or unwrapped from the vial to free the removable overcap. The overcap may then be lifted from the vial in order to gain access to the spike.
Upon removal of the overcap from the vials of the prior art, the spike or needle is exposed. Such exposure may cause contamination from the atmosphere.
A significant technical weakness of the vials of the prior art is that during penetration of the spike of the vial into the parenteral solution container, air may be drawn into the parenteral solution. Such air is drawn by the vacuum maintained in the parenteral solution container at locations around the spike, which are characterized by uneven spike penetration.
Accordingly, an improved additive vial is desired which is characterized by relatively simple, yet efficient, construction, assembly and operation. In particular, such improved additive vial should consist of relatively few parts, will have a compact construction and should prevent leakage and minimize contamination during transfer of its contents to an evacuated parenteral solution container.